FDA.reportPublic FDA data

AVID TruCustom

Primary DI
10809160168844
Brand
AVID TruCustom
Company
AVID MEDICAL, INC.
Model
RMRI100_0001
Published
2017-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FPASet, administration, intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FPASet, Administration, IntravascularGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K810921000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K810921000MALE LUER LOCK PLUGSProcedure Products, Inc.1981-05-21FPA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160168841PackageGS130In Commercial Distribution
10809160168844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916016884120809160168841
1080916016884410809160168844

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose catheter connector, sterileA small sterile device intended to create a mechanical union between a catheter and an external device (non-dedicated) typically via a Luer connection; it has an intended use profile that is not dedicated to a specific type of catheter (i.e., can be applied to catheters specific to different anatomical sites and body fluids). It may be used to permit catheter insertion and/or manipulation, and/or to facilitate delivery or extraction of substances through the catheter lumen. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
015623119
Device count
1
DM exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160541340HalyardMMBF002-03_0006MMBF002-032026-10-23
10809160541357HalyardVATX010-15_0013VATX010-152026-10-23
10809160541364HalyardMMBF007-04_0004MMBF007-042026-10-23
10809160541371HalyardMMBF006-07_0010MMBF006-072026-10-23
10809160541388HalyardMMBF017-05_0005MMBF017-052026-10-23
10809160541395HalyardMMBF027-01_0010MMBF027-012026-10-23
10809160541401HalyardMMBF024-02_0003MMBF024-022026-10-23
10809160541418HalyardMMBF016-06_0005MMBF016-062026-10-23
10809160541425HalyardMMBF008-04_0009MMBF008-042026-10-23
10809160541432HalyardMMBF010-04_0003MMBF010-042026-10-23
10809160541449HalyardMMBR003-02_0028MMBR003-022026-10-23
10809160541456HalyardMMBR007-02_0017MMBR007-022026-10-23
10809160541463HalyardMMBR002-02_0028MMBR002-022026-10-23
10809160541111HalyardMMSY007-02_0006MMSY007-022026-10-22
10809160541128HalyardSHAN099-01_0002SHAN099-012026-10-22
10809160541142HalyardOGHT55-02OGHT55-022026-10-22
10809160541159HalyardMMTN019-02_0016MMTN019-022026-10-22
10809160541166HalyardVATX013-13_0004VATX013-132026-10-22
10809160541173HalyardMMNP007-03_0010MMNP007-032026-10-22
10809160541180HalyardVATX015-10_0009VATX015-102026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885403533822BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-23
00850017421585twiistSEQUEL MED TECH, LLCFPA2026-10-19
10885403520631BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533839BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
10885403533846BD Alaris Pump Infusion SetBD Switzerland SàrlFPA2026-10-09
01081633602518WUSA6010NEOCHILD, LLCFPA2026-10-08
10612479285993McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
10612479286013McKessonMCKESSON MEDICAL-SURGICAL INC.FPA2026-10-06
04046955765164IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-27
00884450707104Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
00884450707111Merit Medical®Merit Medical Systems, Inc.FPA2026-09-26
04046955114559IV Administration SetB. BRAUN MEDICAL INC.FPA2026-09-19
10850083986008TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986015TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986022TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10850083986039TrueCare BiomedixU.S. Infusion, LLCFPA2026-08-17
10813153027339CodanCodan US CorporationFPA2026-07-31
10813153028312CodanCodan US CorporationFPA2026-07-31
10850048235196HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
10850048235264HMG IV Administration SetHartman Medical Group LLCFPA2026-07-31
20850048235193HMG Needleless PRN connectorHartman Medical Group LLCFPA2026-07-31
00382903935314NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935321NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935338NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935345NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935352NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935369NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935376NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
00382903935383NexivaBECTON, DICKINSON AND COMPANYFPA2026-07-30
10813153028329CodanCodan US CorporationFPA2026-07-17